Evaluation of Alpha DaRT Radiation Device Combined with Chemotherapy for Locally Advanced or Metastatic Pancreatic Cancer

What this Trial Is About

Researchers are conducting a multi-center clinical study to evaluate the safety and effectiveness of Alpha DaRT, a device that emits alpha radiation, combined with chemotherapy for patients with locally advanced or metastatic pancreatic cancer. The study aims primarily to assess the safety of this combination by monitoring device-related adverse events. Additionally, the study will evaluate the treatments effectiveness by looking at overall and progression-free survival, pain control, and the rate of surgical resection in patients with locally advanced cancer. Participants are divided into two groups based on their cancer stage one with locally advanced pancreatic cancer and the other with metastatic pancreatic cancer. Each group will receive chemotherapy regimens such as mFOLFIRINOX or GemcitabineAbraxane. During the first four cycles of chemotherapy, patients will undergo placement of the Alpha DaRT device, which is inserted into the tumor via endoscopy and releases short-lived alpha-emitting atoms to target the cancer. Throughout the study, participants will be closely monitored for safety and treatment response. Assessments include tracking serious adverse events for up to 24 months, evaluating pain response 30 days and two months after the procedure, and determining the percentage of locally advanced cases that become surgically resectable at six and 24 months. Follow-up continues for six months after enrollment to observe outcomes and side effects, providing a comprehensive overview of the treatments impact over time.

Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer